Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
61 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: based on lowest derived occupational exposure limit for butan-1-ol
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: occupational exposure limit
Value:
61 mg/m³
Explanation for the modification of the dose descriptor starting point:

The value derived is based on the worst case time-weighted average concentration (8-h working period) as derived by Belgium, Finland, Italy and Switzerland of 61 mg/m3. This assessment is based on irritant effects to the eyes, no further details are available, but occupational limit values in general take into account several assessment factors. Therefore no additional assessment factors are included.

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for interspecies differences (allometric scaling):
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for other interspecies differences:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for intraspecies differences:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for the quality of the whole database:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed. This value is based on evaluation of public literature
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
61 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: based on lowest derived occupational exposure limit for butan-1-ol
Overall assessment factor (AF):
1
Dose descriptor:
other: occupational exposure limit
Value:
61 mg/m³
AF for dose response relationship:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for differences in duration of exposure:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for interspecies differences (allometric scaling):
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for other interspecies differences:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for intraspecies differences:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed.
AF for the quality of the whole database:
1
Justification:
The occupational exposure limit for inhalation is based on exposure during work for 8 h, no further assessment factor is needed. This value is based on evaluation of public literature
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
125 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based the effects of butan-1-ol using absorption percentages of 100% for oral and 10% for dermal absorption

AF for dose response relationship:
1
Justification:
The dose response relationship is considered unremarkable, therefore no additional factor is used.
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default allometric scaling factor for rat to human
AF for other interspecies differences:
2.5
Justification:
default factor for differences in metabolism (worst case as the metabolism of butanol in humans and rats is very similar)
AF for intraspecies differences:
5
Justification:
default value for worker exposure
AF for the quality of the whole database:
2
Justification:
data based on literature sources
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Consumer exposure is expected only due to use of aluminium tributanolate in cosmetics and pharmaceutical products. These uses are covered by different legislation and are not required to be included in the chemical safety report according to REACH Article 2, paragraph 5(a).